FDA.reportPublic FDA data

Cefdinir

Product NDC
0781-2176
11-digit product format
007812176
Labeler code
0781
Product ID
0781-2176_977d4566-20b3-4909-ad00-6cbea017798d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065330
Marketing category
ANDA
Marketing start
2007-04-06
Substance
CEFDINIR
Active strength
300 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefdinir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFDINIR300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCI0FAO63WC
Rxcui200346

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-2176-01Cefdinir100 in 1 BOTTLECAPSULE10014
0781-2176-60Cefdinir60 in 1 BOTTLECAPSULE6014
0781-2176-64Cefdinir3 in 1 CARTONCAPSULE314
0781-2176-64Cefdinir1 in 1 CARTONCAPSULE114
0781-2176-69Cefdinir5 in 1 CARTONCAPSULE514
0781-2176-69Cefdinir10 in 1 BLISTER PACKCAPSULE1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2176-60EA - Each0781-2176e6a12472-9d90-432d-af7b-ab10203c483b12012-07-24
0781-2176-64EA - Each0781-2176b6385fc7-a050-40a3-a9ab-2ea11c138fe712012-07-24
0781-2176-69EA - Each0781-2176ac043ca3-3201-416f-a8c1-d1b406d3c43612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR CAPSULE [SANDOZ INC]11
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR CAPSULE [SANDOZ INC]11
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFDINIR CAPSULE [SANDOZ INC]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEFDINIR CAPSULE [SANDOZ INC]11
GELATININACTIVE INGREDIENT2G86QN327LCEFDINIR CAPSULE [SANDOZ INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR CAPSULE [SANDOZ INC]11
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ICEFDINIR CAPSULE [SANDOZ INC]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR CAPSULE [SANDOZ INC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFDINIR CAPSULE [SANDOZ INC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2176CEFDINIR CAPSULE [SANDOZ INC]14Current NDC, Legacy NDC, 6 package rows20200416_38f6adf7-e26c-4764-8ec9-360813874dd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSN38f6adf7-e26c-4764-8ec9-360813874dd414
200346cefdinir 300 MG Oral CapsuleSCD38f6adf7-e26c-4764-8ec9-360813874dd414
200346cefdinir 300 MG Oral CapsulePSN4185590d-0197-72bb-e054-00144ff88e886
200346cefdinir 300 MG Oral CapsuleSCD4185590d-0197-72bb-e054-00144ff88e886
200346cefdinir 300 MG Oral CapsulePSN76a31bff-99f3-e0d5-e053-2991aa0a00fa3
200346cefdinir 300 MG Oral CapsulePSNf30d01e3-0839-4928-a45a-b46c89aa454c3
200346cefdinir 300 MG Oral CapsuleSCD76a31bff-99f3-e0d5-e053-2991aa0a00fa3
200346cefdinir 300 MG Oral CapsuleSCDf30d01e3-0839-4928-a45a-b46c89aa454c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2176-0100781217601100 CAPSULE in 1 BOTTLE (0781-2176-01) 100 capsule2007-04-060000-00-00NoNoCurrent
0781-2176-600078121766060 CAPSULE in 1 BOTTLE (0781-2176-60) 60 capsule2007-04-060000-00-00NoNoCurrent
0781-2176-64007812176643 CARTON in 1 CARTON (0781-2176-64) / 1 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK3 carton2007-04-060000-00-00NoNoCurrent
0781-2176-69007812176695 BLISTER PACK in 1 CARTON (0781-2176-69) / 10 CAPSULE in 1 BLISTER PACK5 blister pack2007-04-060000-00-00NoNoCurrent